- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01361464
Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia
Phase 2 Trial of R115777 in Previously Untreated Older Adults With AML and Baseline Presence of a Specific 2-Gene Expression Signature Ratio
Visão geral do estudo
Status
Condições
- Leucemia Mielóide Aguda Secundária
- Leucemia Mielóide Aguda em Adultos Não Tratada
- Leucemia Monoblástica Aguda do Adulto
- Leucemia Monocítica Aguda do Adulto
- Leucemia Mielóide Aguda do Adulto com Inv(16)(p13.1q22); CBFB-MYH11
- Leucemia Mielóide Aguda do Adulto com Maturação
- Leucemia Mielóide Aguda em Adultos com Diferenciação Mínima
- Leucemia Mielóide Aguda do Adulto Com t(16;16)(p13.1;q22); CBFB-MYH11
- Leucemia Mielóide Aguda do Adulto sem Maturação
- Leucemia Mielomonocítica Aguda do Adulto
- Leucemia Mielóide Aguda Relacionada a Agentes Alquilantes
- Leucemia Megacarioblástica Aguda do Adulto
- Adulto Eritroleucemia
- Leucemia Eritroide Pura do Adulto
- Leucemia Mielóide Aguda do Adulto Com t(9;11)(p22;q23); MLLT3-MLL
- Leucemia Mielóide Aguda do Adulto Com t(8;21)(q22;q22); RUNX1-RUNX1T1
Intervenção / Tratamento
Descrição detalhada
PRIMARY OBJECTIVES:
I. To determine the complete remission (CR) rate in acute myeloid leukemia (AML) patients prospectively selected for tipifarnib (ZARNESTRA) treatment on the basis of a 2-gene signature (RASGRP1:APTX ratio) in bone marrow aspirates.
SECONDARY OBJECTIVES:
I. To determine the median overall and 1-year survival of patients treated with this regimen II. To determine the median relapse-free survival of patients treated with this regimen.
III. To determine the safety of this regimen in these patients IV. To determine the immunophenotypic expression of RASGRP1 on baseline bone marrow blasts and assess correlation with PCR-based detection.
OUTLINE: This is a multicenter study.
Patients receive tipifarnib orally twice daily on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Bone marrow aspirate and/or biopsy are collected at baseline and on day 28 of course 1 and 2 for RasGRP1 protein expression analysis by qRT-PCR.
After completion of study therapy, patients are followed up every 30 days.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
-
-
Florida
-
Tampa, Florida, Estados Unidos, 33612
- Moffitt Cancer Center
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30342
- Blood and Marrow Transplant Group of Georgia
-
Atlanta, Georgia, Estados Unidos, 30322
- Emory University/Winship Cancer Institute
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
-
-
New York
-
New York, New York, Estados Unidos, 10065
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, Estados Unidos, 10065
- Weill Medical College of Cornell University
-
-
North Carolina
-
Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Previously untreated acute myeloid leukemia (AML) (de novo or secondary)
- No diagnosis of acute promyelocytic leukemia (APL)
- Deemed unsuitable for or refuses standard induction chemotherapy
- RASGRP1:APTX ratio >= 5, through bone marrow screening
- No patients with known leukemic involvement of the central nervous system
- ECOG performance status =< 2
- No WBC >= 30,000/uL (hydroxyurea permitted up to 24 hours prior to initiation of therapy)
- Serum creatinine less than 1.5 times the upper limit of the normal range (ULN) (National Cancer Institute [NCI] Common Toxicity Criteria [CTC] Grade 1)
- Total bilirubin less than 1.5 times ULN (unless the increase is unequivocally due to hemolysis or Gilbert syndrome)
- ALT and AST less than 2.5 times ULN (NCI CTC Grade 1)
- Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
- No symptomatic neuropathy of grade 2 or worse
- No uncompensated disseminated intravascular coagulation (DIC) or uncontrolled bleeding
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to tipifarnib (R115777), such as the imidazole drugs, including clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, isoconazole, sulconazole, ticonazole, or terconazole
- No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with R115777; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; known HIV-positive patients NOT on antiretroviral therapy AND with a CD4 cell count >= 400/mm^3 are eligible
- No other concurrent cytotoxic or biologic antileukemic therapy
- No patients who are receiving any other investigational agents
Use of enzyme-inducing anticonvulsants (e.g., phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine) while taking tipifarnib (R115777) is contraindicated
- If clinically indicated, subjects may use non-enzyme-inducing anticonvulsants during treatment with R115777
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Treatment (tipifarnib)
Patients receive tipifarnib orally twice daily on days 1-21.
Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
Estudos correlativos
Dado PO
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Complete Remission (CR) Rate
Prazo: From first treatment through follow up period, an expected average of 12 months
|
Complete Remission (CR) rate in Acute Myelogenous Leukemia (AML) patients prospectively selected for R115777R115777 (ZARNESTRA) treatment on the basis of a 2-gene signature (RASGRP1:APTX ratio) in bone marrow aspirates.
AML Complete Remission: Bone marrow aspiration - Less than 5% leukemic blasts, Auer rods not detected; Peripheral blood counts - Absolute neutrophil count >/= 1,000/mm^3, Platelet count >/= 100,000/mm^3, Leukemic blasts not present; Blood-product transfusion independence; Absence of extramedullary leukemia.
|
From first treatment through follow up period, an expected average of 12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Median Overall Survival (OS)
Prazo: From first treatment through follow up period, an expected average of 12 months
|
Overall survival is calculated from the first day of R115777 treatment and lasts until the date of death recorded on the case report form (CRF).
|
From first treatment through follow up period, an expected average of 12 months
|
Median 1-Year Survival Rate
Prazo: 1 year
|
Prior to the early discontinuation of the study (for not meeting the primary endpoint of at least 3 CR/CRi after 2 cycles), investigators had planned to calculate one year survival from Kaplan Meier estimates.
|
1 year
|
Number of Participants With Relapse Free Survival
Prazo: 7 months
|
Relapse-free survival is calculated from the date of documentation of complete remission/morphologic complete remission with incomplete blood count recovery (CR/CRi) until disease relapse or death from any cause.
|
7 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jeffrey Lancet, Moffitt Cancer Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias por Tipo Histológico
- Neoplasias
- Doenças da Medula Óssea
- Doenças Hematológicas
- Distúrbios mieloproliferativos
- Leucemia
- Leucemia Mieloide
- Leucemia Mieloide Aguda
- Leucemia Mielomonocítica Aguda
- Leucemia Monocítica Aguda
- Leucemia Megacarioblástica Aguda
- Leucemia Eritroblástica Aguda
- Agentes Antineoplásicos
- Tipifarnibe
Outros números de identificação do estudo
- NCI-2011-02589 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- U01CA070095 (Concessão/Contrato do NIH dos EUA)
- N01CM00071 (Concessão/Contrato do NIH dos EUA)
- P30CA076292 (Concessão/Contrato do NIH dos EUA)
- N01CM00100 (Concessão/Contrato do NIH dos EUA)
- 16572
- CDR0000699713
- 8977 (Outro identificador: CTEP)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Análise laboratorial de biomarcadores
-
ORIOL BESTARDConcluídoTransplante Renal | Infecção por CMVEspanha, Bélgica
-
Central and North West London NHS Foundation TrustBritish HIV Association (BHIVA)Ainda não está recrutandoInfecções por HIV | Hepatite B
-
Bandim Health ProjectResearch Center for Vitamins and Vaccines, Statens Serum InstituteRescindidoMortalidade infantil | BCGGuiné-Bissau
-
McGill University Health Centre/Research Institute...Northwestern UniversityRecrutamentoApnéia da PrematuridadeCanadá
-
Postgraduate Institute of Medical Education and...Desconhecido
-
Riyadh Colleges of Dentistry and PharmacyKing Faisal Specialist Hospital & Research CenterDesconhecidoMucosite Oral